MAUDE Adverse Event Report: COLOPLAST A/S TITAN SCROTAL ZERO ANG 20CM; INFLATABLE PENILE PROSTHESIS

Model Number ES89202400

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, tubing too long, put in new pump.

Manufacturer Narrative

The device was discarded by the explanting facility.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.Review of nonconformances revealed no nonconformance with this lot that would have contributed to the event.Based on the information received, the most likely root cause of the event may be attributed to incorrect sizing during the implant procedure.Quality accepts the physician's observations of such as the reason for surgical intervention.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, no further corrective action is required at this time.

• Brand Name: TITAN SCROTAL ZERO ANG 20CM
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7418132
• MDR Text Key: 105099308
• Report Number: 2125050-2018-00287
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487368
• UDI-Public: 05708932487368
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ES89202400
• Device Catalogue Number: ES89202400
• Device Lot Number: 5988743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR